HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312

Stimulator, Muscle, Powered

HOME CARE TECHNOLOGY CO., LTD.

The following data is part of a premarket notification filed by Home Care Technology Co., Ltd. with the FDA for Home Care Vareious Models Of Powered Muscle Stimulator, Ht-311, Ht-311n, Ht-312.

Pre-market Notification Details

Device IDK022998
510k NumberK022998
Device Name:HOME CARE VAREIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-311, HT-311N, HT-312
ClassificationStimulator, Muscle, Powered
Applicant HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus,  OH  43235
ContactShu-chen Cheng
CorrespondentShu-chen Cheng
HOME CARE TECHNOLOGY CO., LTD. 2064 TAMARIN DR. Columbus,  OH  43235
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-09
Decision Date2003-05-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04719873683208 K022998 000

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